BACKGROUND AND AIM OF THE STUDY: The Sorin Bicarbon (SB) bileaflet valve, available since 1990, has a good clinical safety profile. The study aim was to assess the long-term clinical results following implantation, plus hemodynamic and hematological aspects of the valve. METHODS: A total of 195 SB prostheses (100 aortic, 67 mitral, 14 double valve replacements) was implanted in 181 patients (108 males, 73 females) since 1991. RESULTS: Mean age at implantation was 60.5 +/- 10.8 years. Actuarial analysis at 9.0 years showed an overall survival of 63.9 +/- 5.5%; 28.2% of deaths were early (n = 11), and 71.8% late (n = 28). Freedom from thrombosis was 99.4 +/- 0.6% (one early event, successfully reoperated on), and from embolic events was 86.3 +/- 4.7%. Freedom from endocarditis and hemorrhagic complications were respectively 98.1 +/- 1.1% and 98.6 +/- 0.9%. No occurrence of hemolysis was reported. Freedom from non-structural valve dysfunction was 98.7 +/- 0.9%, and from reoperation was 96.1 +/- 1.6%. Hemodynamic evaluation by echocardiography and hematological testing was performed at 7.0 +/- 1.3 years (range 5-9 years) in a subset of 31 patients (20 males, 11 females). Mean valve size was 23.9 mm for aortic mitral. Echocardiography showed that aortic valves had a mean effective orifice area (EOA) of 2.26 +/- 1.28 cm2, with peak and mean pressure gradients of 23.6 +/- 14.6 and 12.9 +/- 8.1 mmHg, respectively. The mean EOA of mitral valve prostheses was 2.67 +/- 0.66 cm2, with peak and mean pressure gradients of 12.2 +/- 4.5 and 3.8 +/- 1.6 mmHg, respectively. Overall mean hemoglobin was 13.4 +/- 1.35 g/dl, and serum lactate dehydrogenase 630 +/- 13 IU/l. Serum haptoglobin was detectable in one patient only, and the mean reticulocyte count was 1.24 +/- 0.51%. CONCLUSION: In the present authors' experience, the Sorin Bicarbon prosthesis has low complication rates and maintains an excellent hemodynamic function over time. Hemolytic potential is insignificant with this valve.
BACKGROUND AND AIM OF THE STUDY: The Sorin Bicarbon (SB) bileaflet valve, available since 1990, has a good clinical safety profile. The study aim was to assess the long-term clinical results following implantation, plus hemodynamic and hematological aspects of the valve. METHODS: A total of 195 SB prostheses (100 aortic, 67 mitral, 14 double valve replacements) was implanted in 181 patients (108 males, 73 females) since 1991. RESULTS: Mean age at implantation was 60.5 +/- 10.8 years. Actuarial analysis at 9.0 years showed an overall survival of 63.9 +/- 5.5%; 28.2% of deaths were early (n = 11), and 71.8% late (n = 28). Freedom from thrombosis was 99.4 +/- 0.6% (one early event, successfully reoperated on), and from embolic events was 86.3 +/- 4.7%. Freedom from endocarditis and hemorrhagic complications were respectively 98.1 +/- 1.1% and 98.6 +/- 0.9%. No occurrence of hemolysis was reported. Freedom from non-structural valve dysfunction was 98.7 +/- 0.9%, and from reoperation was 96.1 +/- 1.6%. Hemodynamic evaluation by echocardiography and hematological testing was performed at 7.0 +/- 1.3 years (range 5-9 years) in a subset of 31 patients (20 males, 11 females). Mean valve size was 23.9 mm for aortic mitral. Echocardiography showed that aortic valves had a mean effective orifice area (EOA) of 2.26 +/- 1.28 cm2, with peak and mean pressure gradients of 23.6 +/- 14.6 and 12.9 +/- 8.1 mmHg, respectively. The mean EOA of mitral valve prostheses was 2.67 +/- 0.66 cm2, with peak and mean pressure gradients of 12.2 +/- 4.5 and 3.8 +/- 1.6 mmHg, respectively. Overall mean hemoglobin was 13.4 +/- 1.35 g/dl, and serum lactate dehydrogenase 630 +/- 13 IU/l. Serum haptoglobin was detectable in one patient only, and the mean reticulocyte count was 1.24 +/- 0.51%. CONCLUSION: In the present authors' experience, the Sorin Bicarbon prosthesis has low complication rates and maintains an excellent hemodynamic function over time. Hemolytic potential is insignificant with this valve.